The present invention relates to apparatus, system and method for real-time endovaginal sonography guidance of intra-uterine, cervical and tubal procedures.
Endovaginal ultrasound transducers for diagnosis and monitoring of obstetric and gynecological disorders are well known in the art.
Examples of endovaginal ultrasound transducers for real-time monitoring and guidance of surgical procedures are disclosed in U.S. Pat. Nos. 4,497,325, 4,671,292, 4,681,103, 4,742,829, 4,877,033, 4,883,059 and 5,280,427, which are incorporated by reference as if fully set forth herein.
Most of these patents provide ultrasound transducers including a needle and/or catheter guide attached thereto for introducing a needle and/or catheter to a targeted tissue. However, the surgical procedures which may be carried out by such endovaginal ultrasound transducers are usually very limited and include puncturing and drainage of abscesses, local tissue sampling and fluid collection. As such, the use of such transducers for real-time monitoring of intra uterine, cervical and tubal procedures is very limited.
Transabdominal ultrasound is not routinely used for real-time monitoring and guidance of such surgical procedures due to its relatively limited resolution, the need to keep the patient's urinary bladder full during operation, and the need of extra-operating stuff.
As a consequence, such surgical procedures are in many cases carried out blindly, relying solely on the "feel" transmitted through manual manipulation of the instrument and the surgeon's experience. However, when the position or size of the uterus is incorrectly diagnosed by the surgeon, uterine perforation may occur. The chances of perforation are higher in the presence of cervical stenosis or uterine malignancy (endometrial or sarcoma).
The main dangers of such uterine perforation include bleeding and trauma to the abdominal viscera as well as damage to internal organs such as bowel, omentum, mesentery, ureter and fallopian tube. Thus, exploration of the abdominal cavity by laparoscopy or laparotomy is often needed due to accidental uterine perforation. Other poor outcomes of blind operation include, for example, failure to completely remove uterine tissues such as placental or fetal tissues, which necessitates a second curettage under general anesthesia, or misplacement of foreign bodies or embryos therein.
Due to the dangers associated with performing non-ultrasound guided procedures, an apparatus for real-time endovaginal sonography guidance of intra-uterine, cervical and tubal surgical and non-surgical procedures has been devised. WO 99/03399 describes an apparatus which includes a cervical holder for holding the patient's cervix and an attached connector for interconnecting an ultrasound transducer to the cervical holder. In contrast to the prior art devices described hereinabove the apparatus described in WO 99/03399 can be used to guide and monitor, in real time, intra uterine, cervical and tubal procedures such as, for example, curettage or evacuation of the uterine cavity for diagnostic and/or therapeutic purposes, and the like.
Although this apparatus provides several advantages over the prior art, which advantages significantly improve the precision with which an intra uterine, cervical and tubal procedures can be performed, several limitations are still inherent to this apparatus.
These limitations arise from the non-compliant nature of this apparatus. As shown in FIG. 1, the apparatus described in WO 99/03399, when in use, is positioned within the vagina and attached via the cervical holder onto cervical tissue, as shown by arrow A. As a result, the ultrasound transducer, connected thereto, contacts a tissue region adjacent to the site of attachment, as shown by arrow B. As such, the site of attachment forms a fulcrum point around which angular movements of the apparatus experienced during the course of a surgical procedure can lead to loss of contact between the ultrasound transducer and the tissue, which loss of contact would result in sub-optimal sonography and a greatly diminished resolution. In addition, movement of the ultrasound transducer in the direction of the tissue region can lead to pressure exerted on the point of attachment which can lead to tissue damage.
There is thus a widely recognized need for, and it would be highly advantageous to have, apparatus, method and system for real-time endovaginal sonography guidance and monitoring of intra-uterine, cervical and tubal surgical and non-surgical procedures devoid of the above limitations.